The Natural Products Association (NPA) has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s recent actions to ban vinpocetine. FDA is collecting public comments following a Federal Register notice that would effectively ban vinpocetine, a widely used product found in safe and legal dietary supplements. The FDA’s decision could have major implications for new dietary ingredient (NDI) notifications, and have an adverse impact on consumers and manufacturers of dietary supplements.
“NPA is the only association in the industry working directly with regulators to explain the precedent that could be set if this rule were allowed to move forward as written,” said Daniel Fabricant, PhD, executive director and CEO of NPA. “We think our comments layout a framework whereby vinpocetine fits as a dietary ingredient under the Federal Food, Drug and Cosmetic Act.
“If this notice goes into effect it will distort the market and confuse manufacturers selling safe and legal products and do nothing to protect consumers,” added Fabricant. “Because of the far-reaching implications this rule could have and the dangerous precedent it would set if allowed to move forward, the FDA should conduct a full economic impact analysis and extend the comment period by a year or withdraw it effective immediately.”
The proposal has also received backlash from senior lawmakers, including Senator Orrin Hatch (R-UT) who recently circulated a letter to the FDA asking the agency to review the impact this proposed rule could have on consumers and manufacturers of dietary supplements.
For more information, visit www.npainfo.org.